TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Toxoplasma Igg Clin-elisa Test Kit Cat. No. 4560.

Pre-market Notification Details

Device IDK860773
510k NumberK860773
Device Name:TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
ContactMarylou Panico
CorrespondentMarylou Panico
CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-03
Decision Date1986-05-23

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